All posts tagged neuroimmune

Dr. Klimas has big plans for the new Institute on Neuroimmune Research at NSU

A Coming Out Party

The coming out party for Dr. Klimas Institute for Neuroimmune Research at Nova Southeastern University (NSU) on January 26th was a year in the making. In 2011 NSU had made her an offer she couldn’t refuse – the opportunity to break down what she called the silo’s that separated researchers, clinicians and educators – and in Dec 2011 she announced, after decades or work at the University of Miami, she was leaving to create a new Institute at NSU.

In the Institute’s first public event, a Patient Conference, she brought together members of the Institute to talk about it. After the Dean’s short introduction, Dr. Klimas gave the first presentation.

The Big Plan : Finding Effective Therapies

(Warning…I frequently take riff’s on the presentations (see Waziry and EBV below) ; if something in these blogs turns out to be incorrect, it’s probably due to my riff :))

Dr. Klimas’ presentation was titled a BIG PLAN and it’s a plan that is focused towards one goal…”Finding Effective Therapies”. Dr. Klimas’ effort is fundamentally oriented towards finding effective therapies and we’ll see how that’s going to work in a later presentation.

Dr. Klimas emphasized that the reason she came to NSU was to create an integrated program that has the clinicians, researchers and educators all working together in a tightly knit group. Each person, she said is engaged in all of it; the doctors are talking with the researchers who are informing the educators. In fact the way the building is structured they have to communicate; everyone eats and meets in the same central meeting/ conference room.

The Institute focuses on two groups, people with chronic fatigue syndrome and people with Gulf War Illness (GWI)

Gulf War Illness (GWI)

Introducing Gulf War Illness Dr. Klimas stated the remarkable fact that fully 1/4 of the Gulf War Vets (that’s 200,000 people and some estimates are higher) returned with a chronic, often disabling multisystem illness ….(sounds like ME/CFS?)…that looks like ME/CFS but is biologically very different. What happened? It appears that a toxic cloud of elements from gas fires, pesticides, vaccines, uranium etc. with the major contributor probably being something we’ve all been exposed to at times; pesticides.

Dig Deeper: Check out a recent fascinating New York Times article suggesting that contaminated dust and Sarin, a close cousin of organophosphate pesticides, were key factors in GWI.

That toxic insult is probably long, long gone but that initial insult appears to have reset many GW participants systems permanently and Dr. Klimas is trying to figure out how to reset the reset button.

Chronic Fatigue Syndrome (ME/CFS)

Dr. Klimas’s test results suggest an insult is still present in ME/CFS. (More on that later). Calling it a terrible illness Dr. Klimas noted that 1/4 or more of people with ME/CFS are fully disabled and many more are partially disabled and that the disease with the funny name is as debilitating as heart disease, end stage kidney disease, AIDS (AIDS !!!) and MS.

She laughed at one idea she come across at times; that people with ME/CFS want to be on disability and the poverty level income that provides them instead of having access to their income they enjoyed previously; yes, she laughed , what a great tradeoff that would be.

The People

Dr Waziry will focus on determining what pathogens are doing to the cells of people with chronic fatigue syndrome

Thus far the Institute has on board researchers specializing in gene expression (Nathanson), viral effects (Waziry), clinical research (Dr. Klimas) and two computational biologists, (Broderick and Cradock) and, I’ve been told, may be adding an animal modeler.

Pathogens

Waziry specializes in a key, key area – detecting how viruses muck up how cells operate. If viruses are present you, of course, want to get at them but if the viruses are gone or are hard to find then finding some sort of viral fingerprint could inform you how the damage occurred, where to target treatments and what viruses to look for would be very helpful and that’s what Waziry is doing.

Given the common infectious trigger in this disorder this slant makes sense; something, after all, happened way back when and for many people it involved a pathogen. If Waziry finds a signature unique to cells that Epstein Barr Virus mutilated, for instance, you’d know your pathogen without having to resort to expensive and not always accurate blood tests. It’s also possible, given the many infectious triggers documented in ME/CFS (EBV, parvovirus, coxsackie, West Nile Virus, Giardia, etc.) that they’re all tweaking the system in the same way. If that’s what’s happening then finding a common immune signature will allow the team to develop simple diagnostic tests for a significant portion of ME/CFS patients.

Computational Biology

The computational biologists are trying to stop the illness cascade in its tracks in chronic fatigue syndrome

Dr. Klimas has fully embraced a new branch of biology called computational biology that uses sophisticated data mining techniques to analyze how our internal systems operate. In fact Dr. Klimas has so fully embraced this type of research that her computational biologists are doing cutting edge work not being done in any other disease.

The computational biologists (Broderick and Crawford) play clean up. Every piece of research and clinical data gathering ultimately ends up in their hands. They’re trying to do something unique in medicine; using data mining techniques to target the molecular source of this disease in time. Think of it as isolating the pebble the started the snow slide that ended creating an avalanche. This isn’t about symptom amelioration anymore; this is about getting at the very beginnings of the system-wide ‘collapse’ that occurred and is still occurring in people with ME/CFS.

The computational biologist are the ones, Dr. Klimas explained, that will ultimately be able to tell her that tweaking this patients HPA axis here, and prodding their immune system over here and here, should stop the cascade of system-wide dysfunction that causes chronic fatigue syndrome…Essentially she wants to cut a relapse or flare off at it’s …er…..start.

We’ll learn more about this approach in Broderick’s talk.

Speeding Up the Process

Dr. Klimas wants to move quickly. No more of this waiting two years for the NIH to respond; Dr. Klimas – through a process Dr. Broderick will outline later – hopes to produce multiple small-scale, phase-1 type clinical trials in house to get the data needed to get pharmaceutical companies interested in drugs that will help ME/CFS patients.

The Institute

At this point the Neuro-immune Institute has 11 staff members including 6 researchers/research assistants, a research coordinator, a Director of Medical Education, two Nurse Practitioners (one of whom has ME/CFS) plus researchers from the University of Miami, University of Alberta, Wright State, and the CDC . And they’re busy with no less than seven different active studies going on at the moment.

Accomplishments of the Past Year

Dr. Klimas announced two encouraging signs; (a) they’d achieved more in the past year than expected and (b) Nova kicked in more than she expected.

In the first year the Institute for Neuroimmune Research has been involved in

Research

a really large DOD grant

Genomic studies

Gene expression and immune regulation study

Gene expression exercise study

GWI animal modeling

CDC – multisite ME/CFS physician study

Chronic Fatigue Initiative Pathogen Study – Dr. Klimas stated that the CFI, which is the most well-endowed ME/CFS research foundation, is motivated to come up with answers quickly as well, and that the pathogen samples in the big Lipkin/Hornig study are being analyzed now. She stated the Institute would continue their work with CFI, suggesting that further studies are around the corner.

Epidemiological Study – stating this has never been done before, this study has tracked people back as far as 10 years and asked them how they’re doing now; thus far 1,000 people have answered the questionnaire. Smiling broadly she said they did it on student stipends; $8,000 (a site?) – a ridiculously low figure – and they’re getting important, never before seen data.

Ampligen Study

Treatment

Doubled the clinical space at their Kendall clinic

Created a new clinic at Davie

An Effective Team – Dr. Klimas mentioned how effective she and Mary Fletcher, whom, she said does not sleep and works weekends (we’ll see evidence of that later :)), were at writing and getting NIH grants. That’s very true; while other ME/CFS researchers have given up on the NIH and few get grants, these two always seem to be in the mix at the NIH. Their ability to consistently get grants for this disorder is extraoardinary and is partially because of the interest in the cutting-edge computational biology approach they’ve taking.

Goals for this Year

Next Dr. Klimas went over their goals for this year.

We’re going to be able to collect huge mountains of data on normal care and make the evidence happen….Dr. Nancy Klimas

Turn the Clinical Database into A Research Database (and then analyze the heck out of it)

The plan, is to integrate her clinical databases into her REDCAP research database, providing her sophisticated tools to analyze treatment effectiveness in her patients, past and present. If you’re part of her clinic (with your permission) you’ll become a research partner as well.

Integrating her clinical database into her research database could allow Dr. Klimas to answer many question about treatment effectiveness

This is big stuff. By putting her patients into a research database made for, well, research and analysis – Dr. Klimas is opening up thousands of records and patient outcomes to analysis. Over time this will bring treatment outcomes out of the fog of individual guesswork and intuition into the clarity of statistically derived analysis. No more waiting for for someone spend two years convincing the NIH to fund a small treatment trial….those trials have effectively been underway in ME/CFS specialists offices for decades; they’re just waiting to be uncovered.

Doxepin elixir is commonly used to aid sleep in chronic fatigue syndrome but how effective is it really? Are there certainly types of patients it works better in? Would some patients do better with Ambien? Nobody really knows the answers to these questions but given the staff and funding they are answerable with this technology.

If this really works, this work, and Dr. Kogelnik at the Open Medicine Institute has similar plans, would be a bonanza for both patients and doctors. Since the CDC doesn’t seem to be able to handle non evidence-based data, we could anticipate an entirely new CDC Toolkit, for example, coming out of this work. Dr. Klimas said they were going to try and sell the project to Medicare.

The ability to do this kind of work is one of the dreams of the electronic digital revolution spreading across the medical field. Only time will tell but hopefully it will deliver on its promise.

How did Dr. Klimas get this project up and running? She walked into an NSU office…and asked them “Do you think we could????” and it was borne. That’s the difference between working in a pro-active environment that is eager for you to succeed and in an institution (my words, not hers) that tolerates your existence but isn’t going to go out of its way to support you.

Other Goals

Establish a Translational Research Program

Begin the DOD modeling studies (see later presentation)

Establish a Nanostring (Gene Expression) Laboratory

Integrate DOD and NIH programs at the new lab

Apply to NIH for Program Project Funds to Pull Everything Together

Train Young Researchers

Five Year Goals

Be a self sustaining unit without the need for extra University funding

Develop funded training program for young faculty

Creating an endowment that supports the program

Broaden international collaborations

Dr. Klimas goal is to create a environment that fosters communication and innovation

Conclusion

Dr. Klimas is getting good support, the Institute is growing rapidly, it’s involved in many studies and it’s got big plans. 2012 was a good first year for the Institute for Neuroimmune Research.